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Authorization of variations requiring assessment (VRA) to the terms of a MA for a veterinary medicinal product already granted via the national procedure


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La proceduraProcedure

Variations requiring assessment (VRA) to the terms of the marketing authorization for a veterinary medicinal product granted via the national procedure are authorized upon application accompanied by all the administrative information and the technical and scientific documentation required by current legislation.

Chi può richiederloWho can apply?

Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.

Cosa serve per richiederloWhat do I need?

Variation application with duty stamp accompanied by:

  • proof of the payment of the fee;
  • eApplication form completed in the relevant parts.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

30-60-90 days according to the type, subject to a possible suspension of time limit.

Quanto costaHow much does it cost?

Fee: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf

Stamp duty: A 16,00 Euro duty stamp on the application.


Payment method

  • Bank Transfer
    Institute: Banca d’Italia
    Current account heading: Ministero della salute - Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC): BITAITRRENT - In the case of a payment from abroad the BIC code must be specified
    Reason for payment: the name of the veterinary medicinal product, the MA number and the European number of the variation must be specified

Come viene comunicato l'esitoHow do I know the outcome?

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

  • Institutional Site

NormativaRelevant law

Go to Trovanormesalute

ContattiContact us

  • Referent Name: Anna Soriero
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 0659943601
    Email: [email protected]
  • Referent Name: Annalisa Montinaro
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 0659942328
    Email: [email protected]

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari

FAQQ&A

not present

App Online

TemiThematic site

Ufficio responsabile del procedimentoOffice


Data ultimo aggiornamento: 21 febbraio 2022


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